Policies, Procedures, Guidelines, and EConsent at TGen
This research involved investigating the various policies, procedures, and guidelines used by fifty research institutions and comparing them to the systems here at TGen to identify differences between human subjects protection program policies and perform a gap analysis between other research institutions and TGen. This revealed a universal lack of information on the various methods of consenting research subjects utilizing electronic consent (EConsent). This research showed evidence of the importance of EConsent in the future of research and suggests that institutions could develop a policy, procedure, or guideline to ensure standardization and the ethical implementation of its use. To approach these topics, literature review was initially conducted followed by data, historical, and legal analysis to further review the pertinent information. Of the fifty institutions that were compared to TGen, only thirteen had policies, procedures, or guidelines concerning consent. Of those, only two had information regarding EConsent. TGen currently utilizes EConsent in several studies, but lacks a policy, procedure, or guideline about EConsent. The information found in this research could be used to develop a policy, procedure, or guideline about EConsent and modify the EConsent currently in use to improve subject participation.
